DELTON ILLUMINATING PIT AND FISSURE SEALING

K050959 · Dentsply International · EBC · May 11, 2005 · Dental

Device Facts

• Record ID: K050959
• Device Name: DELTON ILLUMINATING PIT AND FISSURE SEALING
• Applicant: Dentsply International
• Product Code: EBC · Dental
• Decision Date: May 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

DELTON® Illuminating Pit and Fissure Sealant is indicated for preventive sealing of pits and fissures in primary and secondary dentition in combination with the acid-etch technique.

Device Story

DELTON Illuminating Pit & Fissure Sealant is a dental material used for preventive sealing of pits and fissures in primary and secondary dentition. The device contains a dye that fluoresces blue-white under UVA light, allowing clinicians to inspect sealant margins against natural dentition. It is applied using the acid-etch technique. The device provides a physical barrier to prevent caries and contains releasable fluoride. It is intended for professional use by dental practitioners in a clinical setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Light-cured acrylate chemistry; contains releasable fluoride and a fluorescent dye for UVA-activated margin inspection. Formulated for use with acid-etch technique.

Indications for Use

Indicated for preventive sealing of pits and fissures in primary and secondary dentition using acid-etch technique.

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Predicate Devices

• DELTON® F Pit & Fissure Sealant (K951296)

Submission Summary (Full Text)

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# MAY 11 2005

## 510(k) SUMMARY

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|--------------------------------------------------|
| DATE PREPARED: | April 15, 2005 |
| TRADE OR PROPRIETARY NAME: | DELTON ® Illuminating Pit & Fissure Sealant |
| CLASSIFICATION NAME: | Pit and fissure sealant and conditioner 872.3765 |
| PREDICATE DEVICES: | DELTON® F Pit & Fissure Sealant (K951296) |

## DEVICE DESCRIPTION:

The DELTON® Illuminating Pit & Fissure Sealant is a pit and fissure sealant containing releasable The DECTONS mains a dye that is not visible in ordinary light but fluoresces a blue-white upon exposure to UVA light. Fluorescence provides contrast with natural dentition for margin inspection.

INTENDED USE:

DELTON® Illuminating Pit and Fissure Sealant is indicated for preventive sealing of pits and DELT ON® Inummanding in and secondary dentition in combination with the acid-etch technique.

TECHNOLOGICAL CHARACTERISTICS:

There are no changes in use proposed and fundamental technology, light-cured acrylate chemistry, is unchanged.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in all capital letters. The text is arranged in a circular fashion around the eagle.

MAY 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DENTSPLY International Ms. Helen Lewis Director Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K050959

Trade/Device Name: DELTON Illuminating Pit & Fissure Sealant Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: April 15, 2005 Received: April 18, 2005

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the Fouchar I Jour, Drag, Inag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions or annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Writ), It they of bacyses in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device earred fourther announcements concerning your device in the Federal Register.

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Page 2 - Ms. Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not I least to advisod that 1 Da determination that your device complies with other requirements mean that 1 Dr. I has muse statutes and regulations administered by other Federal agencies. of the Act of ally I out the Act's requirements, including, but not limited to: registration I ou inust comply with are and many (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 807), labeling systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in alle qt radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anon your over substantial equivalence of your device to a premarket notified.com - 110 evice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may ovents of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(K) Number (if known): 056959

#### DELTON® Illuminating Pit & Fissure Sealant Device Name:

## Indications for Use:

DELTON® Illuminating Pit and Fissure Sealant is indicated for preventive scaling of pits . . DELTON® Illuminating Pit and Pissure Scalair 15 mailed with the acid-etch technique.

## Advertising Claims:

- 1. Pit and fissure sealant
- 2. Contains releasable fluoride
- 3. Fluoresces upon exposure to UVA light

X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runnels

. Triston Sign-Off) ് Sision of Anesthesiology, General Hospital, Intection Control, Dental Devices

Number: K050959